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Codeine Phosphate and Guaifenesin

Dosage form: liquid
Ingredients: Codeine Phosphate 10mg in 5mL, Guaifenesin 100mg in 5mL
Labeler: Virtus Pharmaceuticals LLC
NDC Code: 69543-276

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Codeine Phosphate & Guaifenesin oral solution

Drug Facts

Active Ingredients (In each 5 mL = 1 tsp)Purpose
Codeine Phosphate, USP 10 mgAntitussive
Guaifenesin, USP 100 mgExpectorant

Uses
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • your cough to help you sleep
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive.

Warnings

Ask your doctor before use if

  • you have a persistent cough, this may be a sign of a serious condition
  • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • you have a cough that is accompanied by excessive phlegm (mucus)
  • you have chronic pulmonary disease or shortness of breath
  • giving to a child who is taking other drugs

When using this product

  • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
  • may cause or aggravate constipation

Stop use and ask a doctor if

  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • do not exceed 6 doses in 24 hours.
Adults and children 12 years of age and over:2 tsp (10 mL) every 4 hours, or as directed by a doctor.
Children 6 to under 12 years of age:1 tsp (5 mL) every 4 hours, or as directed by a doctor.
Children under 6 years of age:Consult a doctor.

Other information

Each tsp (5 mL) contains 4 mg sodium.
Store at controlled room temperature 15° to 30°C (59° to 86° F). You may report side effects by calling Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088

Inactive ingredients

Alcohol, caramel flavor, cherry flavor, citric acid, FD&C Red #40, glycerin, menthol flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

VIRTUS®
PHARMACEUTICALS

NDC: 69543-276-16

Codeine phosphate and
Guaifenesin oral solution
10 mg/100 mg Per 5 mL

Antitussive
Expectorant

CV

SUGAR FREE

Each 5 mL (1 teaspoonful) contains:
Codeine Phosphate, USP    10 mg
Guaifenesin, USP    100 mg
(WARNING: May be habit-forming)

Alcohol 3.8%

Tamper evident by foil
seal under cap.
Do not use if foil seal is
broken or missing

16 fl. oz. (473 mL)

CODEINE PHOSPHATE AND GUAIFENESIN 
codeine phosphate and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69543-276
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (Codeine Anhydrous) Codeine Phosphate10 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
SACCHARIN SODIUM 
CITRIC ACID MONOHYDRATE 
SORBITOL 
FD&C Red NO. 40 
glycerin 
WATER 
SODIUM BENZOATE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69543-276-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/23/2017
Labeler - Virtus Pharmaceuticals LLC (079659493)

 
Virtus Pharmaceuticals LLC

← See all Codeine Phosphate and Guaifenesin brands

Medically reviewed on Nov 3, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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